Provision Language
4. Biological Materials; Data Sharing
4.1 Biological Materials.
(a) [***] Work. The Parties acknowledge that [***] has possession of and access to certain Atreca Antibody materials [***], and that, under a separate written agreement between Atreca and [***], [***] has performed and is performing services and Development activities pertaining to the Atreca Antibodies [***] (“[***] Work”).
(b) Access to Atreca Biological Materials. In order to enable the Gates MRI to exercise its rights hereunder, Atreca hereby authorizes [***] to provide the Gates MRI with access to any and all Atreca Biological Materials. Atreca will confirm such authorization in writing (including by email) if requested by the Gates MRI or [***]. For clarity, Atreca will not be directly responsible for any supply failure of such Atreca Biological Materials by [***]. The Gates MRI may use and permit its collaboration partners and other sublicensees (including [***]) and contractors to use such Atreca Biological Materials [***] in connection with the exercise of its and their rights pursuant to this Agreement.
4.3 Use of Shared Data.
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(b) By Atreca.
[…]
(iii) Atreca and the Atreca Sublicensees and contractors may use and reference the Gates MRI’s Shared Data (including data generated prior to and including clinical trial applications (e.g., IND submissions or comparable applications to a Regulatory Authority if filed outside of the United States), clinical trial data, documents pertaining to the design or implementation of clinical studies, including the Trial Master File (TMF) or equivalent, and any Regulatory Submissions) and the Gates MRI Biological Materials generated, made, or produced by [***] or other third parties, as sublicensees of the Gates MRI hereunder, in each case subject to the terms of Sections 5.2 and 5.3, and any additional terms as described in Section 4.2, for commercial purposes (i.e., any purposes other than internal research purposes, including Development, Manufacture, and Commercialization of the Atreca Antibodies) outside the Territory (“Commercial License“). Atreca or the Atreca Sublicensee shall have the right to exercise the Commercial License at any time during the term of this Agreement by providing written notification to Gates MRI of the commencement and status of commercial Development efforts (including notification of any sublicense entered into by Atreca with an Atreca Sublicensee for purpose of exercising the Commercial License). In such event, the Gates MRI will, as applicable, (A) grant to Atreca a Right of Reference to the applicable Shared Data and Regulatory Submissions, and (B) authorize [***] or other third parties to supply the applicable Gates MRI Biological Materials to Atreca, subject to availability. For clarity, the Parties agree that any such Gates MRI Biological Materials will be stored by [] and not by [***]. The Gates MRI will not be directly responsible for [***] such Gates MRI Biological Materials by [***].
(c) Atreca may, in connection with its exercise of the Commercial License, request that the Gates MRI cooperate in facilitating a technology transfer of CMC data related to the Licensed Products that is Controlled by the Gates MRI (“Gates MRI CMC Data“). In such event, the Gates MRI (or its contract manufacturer) will cooperate in transferring the Gates MRI CMC Data to Atreca in accordance with a CMC technology transfer plan to be mutually agreed by the Parties in writing (“CMC Technology Transfer“).